Multimodal Therapy for Brain AVM
(TOBAS Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Multimodal Therapy for Brain AVM?
Research shows that combining different treatments like surgery, embolization (blocking blood vessels), and radiosurgery (targeted radiation) can be effective for treating brain arteriovenous malformations (AVMs). Radiosurgery alone has been successful in treating small AVMs, with significant improvement in many patients and fewer complications compared to traditional surgery.12345
Is multimodal therapy for brain AVM generally safe for humans?
How is the multimodal therapy for brain AVM different from other treatments?
The multimodal therapy for brain AVM is unique because it combines neurosurgery, radiation therapy, and endovascular techniques to treat the condition. This approach allows for a more comprehensive treatment by reducing the size of the AVM, preparing it for surgical removal, and addressing associated risks, which is not typically achieved with a single treatment method.411121314
What is the purpose of this trial?
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.
Research Team
Daniel Roy, MD
Principal Investigator
CHUM-Montreal
Eligibility Criteria
The TOBAS study is for patients with brain arteriovenous malformations (AVMs), which are tangles of abnormal blood vessels connecting arteries and veins in the brain. It's open to all such patients, except those needing urgent surgery due to bleeding effects from AVM.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive interventional therapy (neurosurgery, radiosurgery, or endovascular procedures) or conservative management
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on neurological events and status
Nested Trial on Embolization
Pre-surgical or pre-radiosurgery embolization of cerebral AVMs to decrease treatment failures
Treatment Details
Interventions
- Embolization
- Neurosurgery
- Radiation therapy
Neurosurgery is already approved in European Union, United States, Canada for the following indications:
- Brain Arteriovenous Malformations (AVMs)
- Ruptured AVMs
- Unruptured AVMs
- Brain Arteriovenous Malformations (AVMs)
- Ruptured AVMs
- Unruptured AVMs
- Brain Arteriovenous Malformations (AVMs)
- Ruptured AVMs
- Unruptured AVMs
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Centre Hospitalier Régional et Universitaire de Brest
Collaborator